FDA WARNING_LETTER - Manabi Export Panama S.A. - April 25, 2024

On August 14, 2024, the FDA issued a Warning Letter to Manabi Export Panama S.A. following an inspection of their seafood processing facility in Chepo, Panama, on April 24-25, 2024. The inspection revealed serious violations of the seafood HACCP regulation (21 CFR 123), rendering their ready-to-eat (RTE) cooked clam meat in reduced oxygen packaging (ROP) adulterated under 21 U.S.C. § 342(a)(4).

The firm failed to conduct a hazard analysis and implement a written HACCP plan for their RTE clam meat, specifically lacking controls for: natural toxins and environmental chemicals at receiving, pathogenic bacteria survival through cooking, *Clostridium botulinum* toxin formation at labeling, and pathogen growth/toxin formation during post-cooking steps. Additionally, the firm lacked written sanitation procedures and adequate sanitation control records for various critical areas, including food contact surfaces, cross-contamination, handwashing facilities, and pest control, violating 21 CFR 123.11(c).

The FDA acknowledged the firm's May 8, 2024, response, which included a HACCP course receipt, but deemed it inadequate. Manabi Export Panama S.A. must respond within fifteen working days, outlining specific corrective actions, including a copy of their Hazard Analysis and HACCP plan,